The Vermont Supreme Court correctly applied the PREP Act last week to dismiss state-law claims arising from a COVID vaccine. See Politella v. Windham Southeast School Dist., No 23-AP-237, 2024 WL 3545717 (Vt. July 26, 2024) (to be published in A.3d). This was an easy case, and the PREP Act (aka the “Public Readiness & Emergency Preparedness Act”) is a remarkably straightforward federal statute supported by a clear and important public policy—to ensure the availability of effective countermeasures in the event of public health emergencies.
So why is this case blogworthy? Because while many courts have gotten the PREP Act right, a number of others have quizzically refused to apply it, allowing claims to proceed that should never have seen the light of day. The worst offender is the Third Circuit, which essentially rewrote the statute to make an “exclusive” federal claim nonexclusive. Then there was the California plaintiff who alleged that COVID medication resulted in wrongful death, a claim that the PREP Act squarely headed off. The court allowed it because the plaintiff labeled the claim “fraudulent concealment.” The only explanations for these orders are the general hostility that many courts display toward federal preemption and pro-plaintiff sentiment in cases with sympathetic facts. We understand the latter, but you know what Justice Holmes said about hard cases.
The Vermont Supreme Court got it right. To recap, Congress enacted the PREP Act in 2005 to encourage and protect the supply of countermeasures against public health emergencies, such as COVID-19. The Act creates an administrative remedy for allegedly injured individuals, and it grants covered persons immunity from civil liability in connection with countermeasures, like vaccines. There is only one exception: The PREP Act provides “an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct.” 42 U.S.C. § 247d-6d(d)(1) (emphasis added). (You can see our PREP Act Preemption Scorecard here, and we gave you a more complete PREP Act primer here.)
The Politella case in Vermont involved a COVID vaccine clinic set up in a school. In a case of mistaken identity—the school allegedly put a name tag with the wrong name on a six-year-old—a student was vaccinated without parental consent. Politella, at *1. The child was not harmed, but the parents were upset and sued the State, the school district, the school, the principal, the school nurse, and everyone else in sight, alleging claims under Vermont state law.
The PREP Act preempted all the state-law claims against all the defendants. First, all the defendants were “covered persons” under the Act. The plaintiffs cast a wide net, but the Act defines “covered persons” broadly, too. It includes “Program planners,” which means “a State or local government, . . . a person employed by the State of local government, or other person who supervised or administered a program with respect to the administration . . . of a security countermeasure or a qualified pandemic or epidemic product.” Id. at *3. That covered all the defendants and not just the person who happened to roll up this particular student’s sleeve.
Second, the claims were “causally related” to the vaccine’s administration. In addition to the actual administration of the vaccine, the plaintiffs faulted the defendants for removing the student from class and mishandling consent. But all of that was related to the vaccine and the vaccine program, such that the plaintiffs “have alleged only tortious conduct that is causally related to the administration of the vaccine.” Id. at *4.
Third, the vaccine was clearly a covered countermeasure (which the plaintiffs did not dispute). And fourth, the Secretary of Health and Human Services had definitely declared COVID a health emergency in March 2020. The plaintiffs emphasized that Vermont had not declared a public health emergency before their child was vaccinated, but that was irrelevant: “True or not, this observation is immaterial. Nothing in the PREP Act turns on whether a state declaration is in effect.” Id. at *6.
Perhaps most notably, the plaintiffs cited authorities limiting or rejecting PREP Act preemption (see, e.g., wrongfully decided cases referred to above), and the Vermont Supreme Court distinguished and rejected them. The PREP Act preempts all claims against covered persons, including state-law claims and not only claims for willful misconduct. As the court noted, the PREP Act contains an express preemption provision, and “[o]ther state courts faced with similar facts have concluded that state-law claims against immunized defendants cannot proceed in state court in light of the PREP Act’s immunity and preemption provisions.” Id.
These plaintiffs had two choices: File an administrative claim under the PREP Act or file a lawsuit in federal court alleging willful misconduct. They chose neither. Case dismissed. Easy.